Schedules of Controlled Substances: Placement of MAB-CHMINACA Into Schedule I, 4406-4410 [2018-01747]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Proposed Rules]
[Pages 4406-4410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01747]



[[Page 4405]]

Vol. 83

Tuesday,

No. 20

January 30, 2018

Part II





Department of Justice





-----------------------------------------------------------------------





Drug Enforcement Administration





-----------------------------------------------------------------------





21 CFR Part 1308





Schedules of Controlled Substances: Placement of MAB-CHMINACA Into 
Schedule I; Proposed Rule and Temporary rule

Federal Register / Vol. 83 , No. 20 / Tuesday, January 30, 2018 / 
Proposed Rules

[[Page 4406]]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-421]


Schedules of Controlled Substances: Placement of MAB-CHMINACA 
Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration proposes placing N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its 
salts, isomers, and salts of isomers whenever the existence of such 
salts, isomers, and salts of isomers is possible, in schedule I of the 
Controlled Substances Act. If finalized, this action would impose the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances on persons who handle 
(manufacture, distribute, import, export, engage in research, conduct 
instructional activities or chemical analysis, or possess), or propose 
to handle MAB-CHMINACA.

DATES: Comments must be submitted electronically or postmarked on or 
before March 1, 2018.
    Interested persons may file a request for hearing or waiver of 
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers 
of an opportunity for a hearing or to participate in a hearing must be 
received on or before March 1, 2018.

ADDRESSES: Interested persons may file written comments on this 
proposal in accordance with 21 CFR 1308.43(g). Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period. To ensure proper handling of comments, please reference 
``Docket No. DEA-421'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or attach a 
file for lengthier comments. Please go to https://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary. Should you wish to mail a 
paper comment, in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.
     Hearing requests: All requests for a hearing and waivers 
of participation must be sent to: Drug Enforcement Administration, 
Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 
22152. All requests for hearing and waivers of participation should 
also be sent to: (1) Drug Enforcement Administration, Attn: Hearing 
Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) 
Drug Enforcement Administration, Attn: DEA Federal Register 
Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 
22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act (FOIA) applies to all 
comments received. If you want to submit personal identifying 
information (such as your name, address, etc.) as part of your comment, 
but do not want it to be made publicly available, you must include the 
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of 
your comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to https://www.regulations.gov may include 
any personal identifying information (such as name, address, and phone 
number) included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at https://www.regulations.gov for easy 
reference.

Request for Hearing, or Waiver of Participation in Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Such requests or notices must conform to the requirements of 
21 CFR 1308.44(a) or (b), and 1316.47 or 1316.48, as applicable, and 
include a statement of the person's interests in the proposed 
scheduling action, whether the person is adversely affected or 
aggrieved, and the objections or issues, if any, concerning which the 
person desires to be heard at a hearing. Any waiver must conform to the 
requirements of 21 CFR 1308.44(c) and may include a written statement 
regarding the interested person's position on the matters of fact and 
law involved in any hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of a hearing held in relation to this rulemaking is 
restricted to: ``(A) find[ing] that such drug or other substance has a 
potential for abuse, and (B) mak[ing] with respect to such drug or 
other substance the findings

[[Page 4407]]

prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed * * *.'' All requests for 
hearing and waivers participation must be sent to the DEA using the 
address information provided above.

Legal Authority

    The Controlled Substances Act (CSA) provides that proceedings for 
the issuance, amendment, or repeal of the scheduling of any drug or 
other substance may be initiated by the Attorney General (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS); \1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This proposed action is supported by a 
recommendation from the Assistant Secretary for Health of the HHS 
(Assistant Secretary) and an evaluation of all other relevant data by 
the DEA. If finalized, this action would continue \2\ to impose the 
regulatory controls and administrative, civil, and criminal sanctions 
of schedule I controlled substances on any person who handles or 
proposes to handle MAB-CHMINACA.
---------------------------------------------------------------------------

    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
    \2\ MAB-CHMINACA is currently subject to schedule I controls on 
a temporary basis, pursuant to 21 U.S.C. 811(b). 81 FR 8171, Feb. 5, 
2016.
---------------------------------------------------------------------------

Background

    On February 5, 2016, the DEA published an order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place N-(1-amino-
3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA) in schedule I of 
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). 81 FR 6171. That temporary scheduling order was effective on 
the date of publication, and was based on findings by the Acting 
Administrator of the DEA (Acting Administrator) that the temporary 
scheduling of this synthetic cannabinoid was necessary to avoid an 
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). 
Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the 
temporary control of this substance expire two years from the effective 
date of the scheduling order, which was February 5, 2016. However, the 
CSA also provides that during the pendency of proceedings under 21 
U.S.C. 811(a)(1) with respect to the substance, the temporary 
scheduling of that substance could be extended for up to one year. 
Proceedings for the scheduling of a substance under 21 U.S.C. 811(a) 
may be initiated by the Attorney General (delegated to the 
Administrator of the DEA pursuant to 28 CFR 0.100) on his own motion, 
at the request of the Secretary of HHS,\3\ or on the petition of any 
interested party. An extension of the existing temporary order is being 
ordered by the Acting Administrator in a separate action, and is 
published elsewhere in this issue of the Federal Register.
---------------------------------------------------------------------------

    \3\ Because the Secretary of HHS has delegated to the Assistant 
Secretary the authority to make domestic drug scheduling 
recommendations, for purposes of this proposed rulemaking, all 
subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
---------------------------------------------------------------------------

    The Acting Administrator, on his own motion pursuant to 21 U.S.C. 
811(a), is initiating proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule MAB-CHMINACA. The DEA has gathered and reviewed 
the available information regarding the pharmacology, chemistry, 
trafficking, actual abuse, pattern of abuse, and the relative potential 
for abuse for this synthetic cannabinoid. On May 18, 2016, the Acting 
Administrator submitted a request to the Assistant Secretary to provide 
the DEA with a scientific and medical evaluation of available 
information and a scheduling recommendation for MAB-CHMINACA, in 
accordance with 21 U.S.C. 811(b) and (c). Upon evaluating the 
scientific and medical evidence, on January 19, 2018, the Assistant 
Secretary submitted to the Acting Administrator HHS's scientific and 
medical evaluations for this substance. Upon receipt of the scientific 
and medical evaluation and scheduling recommendation from the HHS, the 
DEA reviewed the documents and all other relevant data, and conducted 
its own eight-factor analysis of the abuse potential of MAB-CHMINACA in 
accordance with 21 U.S.C. 811(c).

Proposed Determination to Schedule MAB-CHMINACA

    As discussed in the background section, the Acting Administrator is 
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add MAB-
CHMINACA permanently to schedule I. The DEA has reviewed the scientific 
and medical evaluations and scheduling recommendation, received from 
HHS, and all other relevant data and conducted its own eight-factor 
analysis of the abuse potential of MAB-CHMINACA pursuant to 21 U.S.C. 
811(c). Included below is a brief summary of each factor as analyzed by 
the HHS and the DEA, and as considered by the DEA in its proposed 
scheduling action. Please note that both the DEA 8-Factor and HHS 8-
Factor analyses and the Assistant Secretary's January 19, 2018, letter, 
are available in their entirety under the tab ``Supporting Documents'' 
of the public docket of this action at https://www.regulations.gov, 
under Docket Number ``DEA-421.''
    1. The Drug's Actual or Relative Potential for Abuse: The term 
``abuse'' is not defined in the CSA. However, the legislative history 
of the CSA suggests that the DEA consider the following criteria in 
determining whether a particular drug or substance has a potential for 
abuse: \4\
---------------------------------------------------------------------------

    \4\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 
U.S.C.C.A.N. 4566, 4603.
---------------------------------------------------------------------------

    (a) There is evidence that individuals are taking the drug or drugs 
containing such a substance in amounts sufficient to create a hazard to 
their health or to the safety of other individuals or of the community; 
or
    (b) There is significant diversion of the drug or drugs containing 
such a substance from legitimate drug channels; or
    (c) Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of medical 
advice from a practitioner licensed by law to administer such drugs in 
the course of his professional practice; or
    (d) The drug or drugs containing such a substance are new drugs so 
related in their action to a drug or drugs already listed as having a 
potential for abuse to make it likely that the drug will have the same 
potentiality for abuse as such drugs, thus making it reasonable to 
assume that there may be significant diversions from legitimate 
channels, significant use contrary to or without medical advice, or 
that it has a substantial capability of creating hazards to the health 
of the user or to the safety of the community.
    Review of scientific and medical literature indicates that the 
ingestion of synthetic cannabinoids (SCs) leads to adverse health 
effects. Specifically, adverse effects following ingestion of MAB-
CHMINACA have included: Tachycardia, aggressive or violent behavior, 
confusion, depressed mental status, severe agitation, psychosis, and 
death.

[[Page 4408]]

    The American Association of Poison Control Centers (AAPCC) reported 
7,779 exposures to SCs from January 1 to December 31, 2015. The 
significance of this value is based upon reporting of human exposures 
to SCs since 2011. While 2012-2014 saw a reduction in exposure calls to 
AAPCC, 2015 records demonstrate resurgence in calls to poison centers 
regarding SCs. In addition, the largest monthly tally of calls to 
poison centers ever recorded by AAPCC in reference to SCs occurred in 
April 2015, with 1,512 calls. Overdose data demonstrated that the 
largest outbreak from synthetic cannabinoids occurred from March-May, 
2015, with MAB-CHMINACA as the primary substance confirmed by forensic 
toxicological analysis.
    In a letter to DEA dated June 3, 2015, the HHS stated that there 
are no approved new drug applications or investigational new drug 
applications for MAB-CHMINACA. According to HHS's January 19, 2018, 
letter, MAB-CHMINACA is not approved for medical use in treatment in 
the United States and is not formulated or available for clinical use. 
Therefore the human use of this substance is likely to be on an 
individual's own initiative, rather than on the basis of medical advice 
from a practitioner licensed by law to administer drugs. Further, AAPCC 
reports, published scientific and medical literature, and law 
enforcement reports indicate that individuals are taking MAB-CHMINACA 
on their own initiative, rather than on the medical advice of a 
licensed practitioner.
    As noted by the HHS, MAB-CHMINACA, similar to schedule I SCs, 
displays high affinity binding and potent agonist functional activity 
at the cannabinoid (CB1) receptor, while drug discrimination studies 
have demonstrated the ability of this substance to substitute for THC 
(see factor 2).
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: MAB-CHMINACA is a synthetic cannabinoid that has pharmacological 
effects similar to the schedule I hallucinogen delta-9-
tetrahydrocannabinol ([Delta]9-THC) and other temporarily and 
permanently controlled schedule I SCs. In vitro receptor binding and 
functional assays were conducted with MAB-CHMINACA. In addition, drug 
discrimination assays using Sprague Dawley rats to identify drugs with 
THC-like similar subjective effects demonstrated that MAB-CHMINACA 
fully substituted for the discriminative stimulus effects of THC.
    Based on results from the receptor binding (Ki), CB1 functional 
assay, and drug discrimination studies, the HHS concluded that MAB-
CHMINACA acts as a full psychoactive cannabinoid agonist with no 
antagonist activity, and that MAB-CHMINACA is more potent than THC 
(schedule I), and is similar in activity to JWH-018, AM2201, ADB-
PINACA, AB-FUBINACA, and AB-CHMINACA (schedule I). As stated by the 
HHS, these data indicate that MAB-CHMINACA is more potent than the 
schedule I cannabinoid THC in producing behavioral pharmacological 
effects and shares pharmacological effects with other SCs in schedule 
I, such as JWH-018.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance:
    MAB-CHMINACA shares structural features with a number of schedule I 
SCs such as AKB48, AB-FUBINACA, ADB-PINACA, and AB-CHMINACA. AKB48, AB-
FUBINACA, ADB-PINACA, AB-CHMINACA, and MAB-CHMINACA have the same 
indazole core structure with substitutions at the 1- and 3-positions of 
the indazole ring. All five substances are substituted at the 3-
position with an amide. MAB-CHMINACA was first reported in the 
scientific literature in a Pfizer patent (WO/2009/106980) and 
identified as compound 13. A study conducted by the Department of 
Veterans Affairs Medical Center (Portland, OR) under the interagency 
agreement with the DEA indicated that MAB-CHMINACA binds to the CB1 
receptor and acts as an agonist at this receptor, similar to results 
reported in the original Pfizer patent for compound 13 (WO/2009/
106980).
    The DEA is not aware of any currently accepted medical use in 
treatment in the United States for MAB-CHMINACA. The Administrator of 
the DEA sent a letter dated May 14, 2015, to the Assistant Secretary 
for Health for HHS notifying HHS of DEA's intent to temporarily place 
MAB-CHMINACA in schedule I and solicited comments, including whether 
there was an exemption or approval in effect for the substance under 
the Federal Food, Drug and Cosmetic Act. The Assistant Secretary of 
Health for the HHS advised the DEA that there are no approved new drug 
applications or investigational new drug applications for MAB-CHMINACA 
under section 505 (21 U.S.C. 355) of the Federal Food, Drug, and 
Cosmetic Act. HHS has no objection regarding the temporary placement of 
MAB-CHMINACA in schedule 1 of the CSA. In their scheduling 
recommendation, HHS stated that MAB-CHMINACA is not approved for 
medical use, is not formulated or available for clinical use, and that 
all human self-administration is assumed to be on an individual's own 
initiative, rather than on the basis of medical advice from a 
practitioner licensed by law to administer drugs.
    4. Its History and Current Pattern of Abuse: As noted by the HHS, 
SCs have been developed over the last 30 years as tools for 
investigating the cannabinoid system. The first encounter of SC's 
within the United States occurred in November 2008 by the United States 
Customs and Border Protection. Since then the popularity of SCs and 
their associated products has increased steadily as evidenced by law 
enforcement seizures, public health information, and media reports. 
Amidst multiple scheduling actions placing SCs found on the illicit 
market in schedule I of the CSA, new versions of SCs intended to 
circumvent current controls continue to be encountered. MAB-CHMINACA is 
a SC that was associated with the hospitalization of 125 individuals 
around Baton Rouge and Shreveport, Louisiana in October, 2014. Since 
that time, multiple overdoses and deaths involving MAB-CHMINACA have 
been reported in Texas (in Bryan and Beaumont), Kansas (in Salina), 
Mississippi (in Philadelphia and Jackson), Virginia (in Hampton), and 
in Maryland (in Hagerstown). Specifically, in April 2015 originating in 
Texas, Mississippi and Alabama, the largest nationwide outbreak 
involving SCs was reported by multiple news outlets. State public 
health entities eventually reported over 2,000 overdoses and at least 
33 deaths associated with abuse of SCs across at least 11 States 
between April and May of 2015. Of these overdoses and deaths, 
toxicology results have determined that a majority of overdoses from 
the April/May 2015 cluster were due to ingestion of MAB-CHMINACA. On 
April 29, 2015, the European Monitoring Centre for Drugs and Drug 
Addiction (EMCDDA) reported multiple outbreaks of intoxications within 
the United States resulting from the ingestion of products believed to 
contain SCs. EMCDDA further reported that MAB-CHMINACA had been 
implicated in at least some of the cases. EMCDDA also reported two 
deaths involving MAB-CHMINACA, one in Hungary and the other in Japan.
    5. The Scope, Duration, and Significance of Abuse: Following 
multiple scheduling actions seeking to safeguard the public from the 
adverse effects associated with SCs, law enforcement and health care 
professionals continue to encounter novel SCs thereby indicating the

[[Page 4409]]

continuing abuse of these substances and their associated products. 
After each scheduling action of a SC, drug manufacturers and suppliers 
are adapting at an alarming pace to switch to new SCs to circumvent 
regulatory controls. Even before temporary control of AB-CHMINACA, AB-
PINACA, and THJ-2201 on January 30, 2015, MAB-CHMINACA was available on 
the illicit market. From 2014 through 2016, multiple overdoses and 
deaths have been attributed to the abuse of MAB-CHMINACA. From 
September 2014 to the present, the National Forensic Laboratory 
Information System (NFLIS) has documented over 1,400 reports involving 
MAB-CHMINACA across the following states: Arkansas, Arizona, 
California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, 
Indiana, Iowa, Indiana, Kansas, Kentucky, Louisiana, Minnesota, 
Mississippi, Missouri, North Dakota, New Jersey, Ohio, Oklahoma, 
Pennsylvania, Tennessee, Texas, Virginia and Wisconsin.
    6. What, if Any, Risk There is to the Public Health: MAB-CHMINACA 
was associated with a cluster of 125 subjects who presented to 
emergency facilities within the Baton Rouge and Shreveport, Louisiana 
areas in October 2014. On October 29, 2014, the Secretary of the 
Louisiana Department of Health and Hospitals announced the addition of 
MAB-CHMINACA into Schedule I of the Controlled Dangerous Substances 
section of the Louisiana Administrative Code (LAC 46:LIII.2704.A.3). 
From October 2014 to the present, multiple clusters of overdoses 
involving MAB-CHMINACA and at least eight deaths attributed to the 
abuse of MAB-CHMINACA have been reported.
    Adverse health effects associated with these incidents involving 
MAB-CHMINACA have included: Seizures, coma, severe agitation, loss of 
motor control, loss of consciousness, difficulty breathing, altered 
mental status, and convulsions that in some cases resulted in death. 
One case report noted the presence of MAB-CHMINACA within the body 
fluids and tissue samples of a recently deceased individual. A 
subsequent case report concluded that synergistic toxicity of MAB-
CHMINACA and another SC, 5-fluoro-ADB, led to death.
    The abuse of MAB-CHMINACA, a SC with no accepted medical use in 
treatment in the United States, poses a serious risk to both the abuser 
and those connected to the abuse. HHS noted that by sharing 
pharmacological similarities with schedule I substances ([Delta]9-THC, 
JWH-018 and other temporarily and permanently controlled schedule I 
SCs), SCs pose a risk to the abuser and those connected to the abuse of 
these dangerous substances.
    7. Its Psychic or Physiological Dependence Liability: As stated by 
the HHS, MAB-CHMINACA has a pharmacological profile that is similar to 
other schedule I SCs. Although there are no clinical studies evaluating 
dependence liabilities specific for MAB-CHMINACA, the pharmacological 
profile of this substance strongly suggests that it possesses 
dependence liabilities that are qualitatively similar to, and 
potentially stronger than, THC (schedule I) or marijuana (schedule I).
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: MAB-CHMINACA is not an immediate 
precursor of any controlled substance of the CSA as defined by 21 U.S.C 
802(23).
    Conclusion: After considering the scientific and medical evaluation 
conducted by the HHS, the HHS's recommendation, and the DEA's own 
eight-factor analysis, the DEA finds that the facts and all relevant 
data constitute substantial evidence of the potential for abuse of MAB-
CHMINACA. As such, the DEA hereby proposes to permanently schedule MAB-
CHMINACA as a schedule I controlled substance under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the Assistant Secretary for HHS and review of all 
other available data, the Administrator of the DEA, pursuant to 21 
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    1. MAB-CHMINACA has a high potential for abuse;
    2. MAB-CHMINACA has no currently accepted medical use in treatment 
in the United States; and
    3. There is a lack of accepted safety for use of MAB-CHMINACA under 
medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA) 
including its salts, isomers and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
warrant continued control in schedule I of the CSA. 21 U.S.C. 
812(b)(1).

Requirements for Handling MAB-CHMINACA

    If this rule is finalized as proposed, MAB-CHMINACA would continue 
\5\ to be subject to the CSA's schedule I regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
---------------------------------------------------------------------------

    \5\ MAB-CHMINACA is currently subject to schedule I controls on 
a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 6171, Feb. 5, 
2016.
---------------------------------------------------------------------------

    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) MAB-
CHMINACA, or who desires to handle MAB-CHMINACA, is required to be 
registered with the DEA to conduct such activities pursuant to 21 
U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 
and 1312.
    2. Security. MAB-CHMINACA is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823 and in accordance with 21 CFR 1301.71-1301.93.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of MAB-CHMINACA must be in compliance with 21 U.S.C. 825 and 
958(e), and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture MAB-CHMINACA in accordance with a quota assigned pursuant 
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Any person registered with the DEA to handle MAB-
CHMINACA must have an initial inventory of all stocks of controlled 
substances (including MAB-CHMINACA) on hand on the date the registrant 
first engages in the handling of controlled substances pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including MAB-
CHMINACA) on hand every two years, pursuant to 21 U.S.C. 827 and 958, 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant is required to 
maintain records and submit reports with respect to MAB-CHMINACA, 
pursuant to 21 U.S.C. 827 and 958(e), and in

[[Page 4410]]

accordance with 21 CFR parts 1304 and 1312.
    7. Order Forms. Every DEA registrant who distributes MAB-CHMINACA 
is required to comply with the order form requirements, pursuant to 21 
U.S.C. 828, and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
MAB-CHMINACA must be in compliance with 21 U.S.C. 952, 953, 957, and 
958, and in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving MAB-CHMINACA not authorized 
by, or in violation of, the CSA or its implementing regulations is 
unlawful, and could subject the person to administrative, civil, and/or 
criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures performed ``on the 
record after opportunity for a hearing,'' which are conducted pursuant 
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the 
criteria for scheduling a drug or other substance. Such actions are 
exempt from review by the Office of Management and Budget (OMB) 
pursuant to section 3(d)(1) of Executive Order 12866 and the principles 
reaffirmed in Executive Order 13563.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate 
drafting errors and ambiguity, minimize litigation, provide a clear 
legal standard for affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132

    This proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed rule 
does not have substantial direct effects on the States, on the 
relationship between the national government and the States, or the 
distribution of power and responsibilities among the various levels of 
government.

Executive Order 13175

    This proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes.

Executive Order 13771

    This proposed rule does not meet the definition of an Executive 
Order 13771 regulatory action, and the repeal and cost offset 
requirements of Executive Order 13771 have not been triggered. OMB has 
previously determined that formal rulemaking actions concerning the 
scheduling of controlled substances, such as this rule, are not 
significant regulatory actions under Section 3(f) of Executive Order 
12866.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. On February 5, 2016, 
the DEA published a final order to temporarily place MAB-CHMINACA in 
schedule I of the CSA pursuant to the temporary scheduling provisions 
of 21 U.S.C. 811(h). The DEA estimates that all entities handling or 
planning to handle this substance have already established and 
implemented the systems and processes required to handle MAB-CHMINACA. 
There are currently 16 registrations authorized to handle MAB-CHMINACA 
specifically, as well as a number of registered analytical labs that 
are authorized to handle schedule I controlled substances generally. 
These 16 registrations represent 14 entities, of which 8 are small 
entities. Therefore, the DEA estimates eight small entities are 
affected by this proposed rule.
    A review of the 16 registrations indicates that all entities that 
currently handle MAB-CHMINACA also handle other schedule I controlled 
substances, and have established and implemented (or maintain) the 
systems and processes required to handle MAB-CHMINACA. Therefore, the 
DEA anticipates that this proposed rule will impose minimal or no 
economic impact on any affected entities; and thus, will not have a 
significant economic impact on any of the eight affected small 
entities. Therefore, the DEA has concluded that this proposed rule will 
not have a significant effect on a substantial number of small 
entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted for 
inflation) in any one year * * *.'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
would not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA proposes to amend 21 CFR 
part 1308 as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11:
0
a. Add paragraph (d)(72); and
0
b. Remove and reserve paragraph (h)(1).
    The addition to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

 
 
 
(72) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-                  (7032)
 (cyclohexylmethyl)-1H-indazole-3-carboxamide, (MAB-CHMINACA,
 ADB-CHMINACA)................................................
 

* * * * *

    Dated: January 24, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-01747 Filed 1-29-18; 8:45 am]
 BILLING CODE 4410-09-P